Temporary tooth repair/treatment composition and methods of use thereof

ABSTRACT

A hygienically packaged composition that includes a base layer of a thermoplastic film, a covering film layer that is a heat sealable or pressure sealable adhesive liner that covers the hygienically packaged composition where the hygienically packaged composition is a dental composition, a food composition, or a medicine. The covering film layer includes a stretched dimple in a portion of the covering film layer proximate the hygienically packaged composition thereunder the covering film layer. There is typically a heat or pressure seal around each hygienically packaged composition.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of and claims priority toU.S. patent application Ser. No. 17/720,270, filed on Apr. 13, 2022,entitled “TEMPORARY TOOTH REPAIR/TREATMENT COMPOSITION AND METHODS OFUSE THEREOF.” U.S. patent application Ser. No. 17/720,270 is acontinuation-in-part of and claims priority to U.S. patent applicationSer. No. 17/665,259, filed on Feb. 4, 2022, entitled “TEMPORARY TOOTHREPAIR/TREATMENT COMPOSITION AND METHODS OF USE THEREOF.” Thedisclosures of each of the above applications are hereby incorporatedherein by reference in their entirety.

BACKGROUND

People and other animals with teeth often suffer from sensitive teeth ordamaged teeth that cause a varying degree of discomfort to outrightpain. Prior compositions such as the DENTEMP® Loose Cap & Lost FillingRepair product have attempted to help alleviate the pain of a brokentooth or lost filling where a nerve is accessible or exposed and verysensitive to even air. That compositions includes calcium sulfate,barium sulfate, dimethoxytetraethylene glycol, zinc oxide, eugenol, andethylmethacrylate polymer. Eugenol is a potential allergen.Additionally, the composition is difficult for a layperson to apply anduse effectively. Their instructions are complex and require that thecomposition be applied to a wet tooth and that the wearer wait at leasttwo hours before eating to allow the composition to set. In fact, theinstructions further require that the crown be prepared by carefullyremoving as much old cement as possible from inside the crown. The crownshould be rinsed with water and must be left moist. Next, the existingLoose Cap & Lost Filling Repair Product requires that the person checkand see if the crown will fit on the tooth and, if not, the user can'tproceed to use this product. If it does, a small amount of material,which must be removed from its small container having a small openingwith the included tool (the container must be properly resealed or theremaining product will degrade in short order) and applied in a verysmall amount to the interior of the crown. The crown is then pressed onthe wet tooth and bitten down upon. If the fit is not good the crownmust be removed and the entire process repeated. When the DENTEMP® LooseCap & Lost Filling Repair product is used to replace a lost filling, theapplicator tool is used to remove a small amount of material from thevial, form it into a ball with wet fingers and pressed firmly into thecavity. Next, the person needs to scrape the material off of his/herfinger by scraping a finger along the edge of the tooth. Theinstructions specifically state that one should not lift their fingerstraight up as this might loosen the material in the cavity. The wearershould bite down several times to insure proper bite. The instructionsspecifically also state that the wearer must allow two (2) hours to setbefore eating.

The DENTEMP® Cap & Crown Repair product is similar. This productcontains calcium Sulfate, dimethoxytetraethylene glycol, zinc oxide,potassium sulfate, ethylmethacrylate polymer, and triacetin. Thecomposition is delivered in a small tube. As with the Loose Cap & LostFilling Repair, the instructions are complex. First, the crown must beprepared by carefully removing as much old cement as possible frominside the crown. The crown should next be rinsed well. The tooth areashould be cleaned and rinsed with water and must be left moist. Thecrown is then placed back on the tooth before applying new material.This is done to make sure it fits properly. If one cannot do this, thematerial may not be used and the user of the composition should notproceed and instead exclusively see his/her dentist. If it does fit, thenext step is to ensure that the inside of the crown is dry. The tubecontaining the composition is opened by reversing the cap and punching ahole in the tip of the tube. Thereafter, a small amount of material isapplied onto the upper inside edge of the crown. The tooth area isremoistened, the crown placed on the wet, remoistened tooth and pressedfirmly into position. The wearer is instructed to bite down severaltimes to ensure a proper fit. If the bite is not completely comfortable,the crown should be removed and the process repeated until the crownfeels normal. After 5 minutes, the person must gently remove any excessmaterial and rinse his/her mouth out with water. The instructionsfurther require at least 1 hour to set the composition before eating andspecifically state that the cement will fully set in 1 to 3 hours.Another similar product is DENTEK® TEMPARIN® Max Repair Kit. As with allsuch temporary over the counter dental cements, the product requireswetting by saliva and an appreciable amount of time (typically 1-3hours) for it to harden and set—especially before eating or drinking.When used to cover a missing filling or broken tooth, these temporarycements often produce foul tastes and loose pieces of dental cementbefore and after hardening which require spitting out or are oftenswallowed, and the resulting hardened cement is uncomfortably rough tothe tongue and surrounding mucosal tissues.

SUMMARY

The compositions of the present disclosure do not require excess waittimes for relief or complex instructions to safely and accurately applythe materials and achieve the results desired for providing temporaryrelief from broken teeth, lost fillings, caps and crowns. There is notime needed to wait for the pliable, moisture-activated adhesivecontaining compositions of the present disclosure to set. Moreover, theyare easy to apply, are typically tooth colored, are individually andhygienically packaged, and do not have a foul taste in one's mouth. Thecompositions of the present disclosure also provide a shielded occlusiveeffective treatment that is safely and easily applied to a surface ofthe teeth to deliver active ingredients to provide pain relief fromsensitive teeth or lessen pain from sensitive teeth.

An aspect of the present disclosure is generally directed to a temporarytooth repair composition, which is a dental composition, that includes acombination of an uncured, uncrosslinked silicone high consistencyrubber base material and at least one metal oxide pigment mixed thereinand an adhesive on at least one exterior surface of the temporary toothrepair composition such that finger force applied to the temporary toothrepair composition adheres the temporary tooth repair composition to asurface of a broken tooth. The temporary tooth repair composition may beshaped using fingers and/or the tooth on an opposing side of the mouthsuch that when the temporary tooth repair composition engages thesurface of the broken tooth, the combined broken tooth and temporarytooth repair composition mimic the natural shape and size of the brokentooth prior to the broken tooth being broken. The temporary tooth repaircomposition typically adheres to the broken tooth within 8 seconds orless of being applied to the broken tooth using finger pressure andadheres for at least four hours, more typically at least 8 hours.

Another aspect of the present disclosure is generally directed to apackaged dental composition that includes: a layer of a thermoplasticfilm, a covering film that is a heat sealable or pressure sealableadhesive liner that covers a dental composition and a seal around anindividual use dosage of the dental composition. The dental compositionmay be chosen from: an extrudable dental cement composition that isextrudable through a die at a temperature of from about 10° C. to about50° C. and an extrudable base material that is extrudable through a dieat a temperature of from about 10° C. to about 100° C. The extrudablebase material typically includes at least one of the followingcompounds: (A) a product consisting of one or more hydrocarbon-basedwaxes and optionally also one or more inorganic filler, one or moreorganic filler, or one or more inorganic and organic fillers; (B) anuncured, uncrosslinked silicone high consistency rubber base; and (C) ahydrophobic water insoluble solid material that is malleable at 37° C.or lower and safe for a human oral environment. The extrudable basematerial typically has a surface composition applied thereon. Thesurface composition may include at least one dry, powdered hydrophilicpolymeric substance engaged with and dispersed on one or more surface ofthe extrudable base material and optionally a desensitizing agent.

Yet another aspect of the present disclosure includes at least oneindividually sealed dental composition that includes a layer of athermoplastic film; a covering film that is a heat sealable or pressuresealable adhesive liner that covers a dental cement composition; a sealaround an individual use dosage of the dental cement composition. Theextrudable dental cement composition is extrudable through a die at atemperature of from about 10° C. to about 50° C. The dental cementcomposition may have a textured or non-textured surface thereon and theat least one dry, powdered hydrophilic polymeric substance is typicallyengaged, typically mechanically engaged, with and dispersed on thetextured or non-textured surface of the dental cement composition.

Another aspect of the present disclosure is generally directed toward atleast one individually sealed dental composition that includes: a baselayer that is a thermoplastic film; a covering film having a surfacearea wherein the covering film is a heat sealable or pressure sealableadhesive liner that covers a dental cement composition and having adimpled portion of surface area positioned over the dental cementcomposition; and a hygienic seal around the dental cement composition.The extrudable dental cement composition is extrudable through a die ata temperature of from about 10° C. to about 50° C. The dental cementcomposition may have a coating composition applied to at least onesurface thereof that includes a desensitizing component and at least onedry, powdered hydrophilic polymeric component that is chosen from thegroup consisting of: a polyvinylpyrrolidone, a polyoxazoline, apolyethylene glycol, a starch, a polyacrylic acid, a carbomer, apolyvinyl alcohol, a polyvinyl acetate, a cellulose derivative, apolysaccharide, a polyacrylamide, a N-vinyl caprolactam polymer, acopolymer of methyl vinyl ether and maleic anhydride (PVM/MA), andblends thereof.

Another aspect of the present disclosure generally includes ahygienically packaging a dental composition, a medicine, or a foodcomposition comprising a base layer with a perimeter portion and aninterior portion and a top layer having a perimeter portion and aninterior portion wherein the interior portion of the base layer, theinterior portion of the top layer, or both are flexed to create athinner film portion and wherein the perimeter portion of the base layerand the perimeter portion of the top layer are sealed together typicallyby either heat sealing or pressure sealing the perimeter portion of thetop layer and the perimeter portion of the base layer together andwherein the dental composition, the medicine, or the food composition ispositioned between the interior portion of the base layer and the toplayer.

Yet another aspect of the present disclosure is generally directedtoward a method of making a hygienically packaged product chosen from adental composition, a medicine, or a food composition that includes thesteps of: preparing the dental composition, the medicine, or the foodcomposition; applying a stretching force to either a first film or asecond film or both to stretch a portion of the interior of the firstfilm, the interior of the second film or both and create at least oneflexed portion within the interior of the first film, the second film orboth; placing the dental composition, the medicine or the foodcomposition on a surface of a first film or a surface of the second filmsuch that at least one of the flexed portion of the first film and/orthe flexed portion of the second film are positioned over the dentalcomposition, the medicine, or the food composition of the hygienicallypackaged product; sealing by either heat sealing or pressure sealing,the dental composition, the medicine, or the food composition within theinterior of the first film and the interior of the second film by eitherheat sealing or pressure sealing a perimeter area around the dentalcomposition, the medicine or the food composition to form thehygienically packaged product.

The dental composition, the medicine, or the food composition mosttypically sealed within the hygienically packaging include those thathas a propensity to be significantly depressed if a flexed portion orportions are not utilized. Even with the use of one or more flexedportions, some downward force may be applied to the dental composition,the medicine, or the food composition, but significantly less than wouldotherwise be applied in such a packaging system that does not utilizethe flexing of the film layers. In the case of the dental compositionsof the present disclosure, when the base material is an uncured,uncrosslinked silicone high consistency rubber base, the material istypically significantly mixed with colorant to create a tooth coloredbase material, which results in a softer, more pliable base materialthan if the colorant such as titanium dioxide were not blended therein.The colorant typically is blended with the colorant or other componentsto be blended with the base material such that a substantiallyhomogenous or homogenous distribution of the additives is created.

The stretching force is applied by passing the first film or the secondfilm through a dimpler, which is typically a pneumatic-driven dimplierthat provides at least one piston force to the second film, which istypically over the first film, which is typically a bottom film thatreceives the dental composition, the medicine, or the food compositionbefore the top film with the flexed portion or portions therein areapplied over the dental composition, the medicine, or the foodcomposition.

Another aspect of the present disclosure is generally directed toward amethod that includes the step of using a person's fingers to push adental composition into engagement with a damaged tooth surface of adamaged tooth thereby adhering the dental composition to the damagedtooth surface and covering at least a portion of the damaged toothsurface. The dental composition includes a base material comprising atleast one of the following compounds chosen from the group consistingof: a product consisting of one or more hydrocarbon-based waxes that mayalso include inorganic fillers and/or organic fillers; an uncured,uncrosslinked silicone high consistency rubber base; and a hydrophobicwater insoluble solid material that is malleable at 37° C. or lower andsafe for a human oral environment. The base material typically has atleast one dry, powdered hydrophilic polymeric substance engaged with anddispersed on one or more surface of the base material.

Another aspect of the present disclosure is generally directed toward amethod that includes the steps of: removing a dental composition from asingle use, hygienically packaged system; and applying a finger force tothe dental composition to push the dental composition into engagementwith a damaged surface of a person's tooth. The dental compositioncomprises an extruded base material that is a comprising at least one ofthe following compounds chosen from the group includes: a productconsisting of one or more hydrocarbon-based waxes that may also includeinorganic or inorganic fillers; an uncured, uncrosslinked silicone highconsistency rubber base; and a hydrophobic water insoluble solidmaterial that is malleable at 37° C. or lower and safe for a human oralenvironment. The extruded base material has at least one dry, powderedhydrophilic polymeric substance on an exterior surface of the extrudedbase material.

Yet another aspect of the present disclosure is generally directed to amethod that includes the step of: engaging a dental composition with asurface of a damaged tooth within a person's mouth chosen from the groupconsisting of: a tooth chip, a decayed tooth surface, a tooth cavity, apreviously reshaped tooth surface, a tooth pulp cavity, a cracked toothsurface, and combinations thereof. The dental composition includes: afinger malleable base material that includes an uncured, uncross-linkedsilicone high consistency rubber base and has an exterior surface andwherein exterior surface of the finger malleable base material has atleast one dry, powdered hydrophilic polymeric substance on a surface ofthe extruded base material.

Yet another aspect of the present disclosure includes a kit that has aplurality of sheets where each sheet has a plurality of the single use,hygienically packaged systems conjoined with one another and each of thesingle use, hygienically packaged systems are openable by hand andwithout the use of tools.

These and other aspects, objects, and features of the present inventionwill be understood and appreciated by those skilled in the art uponstudying the following specification, claims, and appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1A is an initial perspective view showing an initial stage ofinstalling the temporary tooth repair composition of the presentdisclosure onto the surface of a broken tooth or with an interior of thetooth exposed to the elements.

FIG. 1B is an intermediate stage perspective view showing anintermediate stage of installing the temporary tooth repair compositionof the present disclosure onto the surface of a broken tooth or over aninterior of the tooth exposed to the elements to shield the tooth fromthe exposure and the often-associated pain of an exposed nerve of adamaged tooth.

FIG. 1C is an end stage perspective view showing an end stage ofinstalling the temporary tooth repair composition of the presentdisclosure onto the surface of a broken tooth or over an interior of thetooth exposed to the elements to shield the tooth from the exposure andthe often-associated pain of an exposed nerve of a damaged tooth wherethe temporary tooth repair composition has been formed, typically byhand and without the use of tools.

FIG. 2 is a perspective view of the following: a tooth repaircomposition that includes an uncoated, uncured (uncrosslinked) siliconehigh consistency rubber base that forms the base material of the toothrepair composition in strip form; a tooth repair composition thatincludes an uncoated, uncured (uncrosslinked) silicone high consistencyrubber base material in strip form and coated with the dry powderadhesive composition used to adhere the tooth repair composition to thetooth surface; and the tooth repair composition that includes theuncured (uncrosslinked) silicone high consistency rubber base coatedwith a dry adhesive and cut in a cuboid shape to be applied to a singletooth.

FIG. 3 is a close-up, perspective view of two rollers, one feeding theuncured (uncrosslinked) silicone high consistency rubber base materialhaving tooth color dispersed therein and used to form the tooth repaircomposition and the other having a knurled or grooved or other texturedsurface to both optionally create indentations into the base materialand also facilitate the retention of the dry powder adhesive material inengagement with the base uncured (uncrosslinked) silicone highconsistency rubber base material where the entire tooth repaircomposition is moldable using finger pressure only and without the useof dental tools by a person other than a dental professional.

FIG. 4 is an enlarged perspective view of a system of the presentdisclosure employing a twin roller system to create the tooth repaircomposition products of the present disclosure. In particular, the drypowder feed cavity is shown in the guide above the knurled or texturedroller to feed dry powder into the textured surface of the roller priorto it being mechanically forced into engagement with the uncured(uncrosslinked) silicone high consistency rubber base material havingwhite coloring component therein to match the natural color of aperson's tooth.

FIG. 5 is an enlarged upper perspective view of the dry powder feedcavity shown in FIG. 4 , but with powder inserted therein.

FIG. 6 is an enlarged perspective view of a roller system of the presentdisclosure with the rollers aligned next to one another with the drypowder feed cavity spaced above the textured surfaced roller and thebase delivering roller and the textured roller adjacent laterally withone another.

FIG. 7 is an enlarged perspective view of a system of the presentdisclosure with the textured roller receiving the dry powder and spacedabove the tooth repair composition uncured (uncrosslinked) silicone highconsistency rubber base material delivering roller.

FIG. 8 is a cross-sectional view of an extrusion die opening that has apattern that may optionally be used to cut/form microgrooves on a singlesurface of the base material of the present disclosure.

FIG. 9A is an elevated side view showing a cutout location of a urethanerod and a coaxial, swivel bar engaging peg.

FIG. 9B is an elevated top view showing a cutout location of a urethanerod and a coaxial, swivel bar engaging peg.

FIG. 9C is a cross-sectional view taken along line C-C in FIG. 9B.

FIG. 10 is an elevated plan view of a swivel bar that holds the urethanerod holder containing a urethane rod therein and allows for adjustableor fixed amount of pressure to be applied to the adhesive and engage itto a surface of the base material.

FIG. 11 is a perspective view of the urethane rod, finger pressuresimulating force applying device.

FIG. 12 is a perspective view of the finger force malleable materialbeing extruded to include PVP receiving microgrooves on a top lengthsurface of the base material.

FIG. 13 is a perspective view of the extruded base material entering theapplication station where hydrophilic polymeric material(s) are applied.

FIG. 14 is a perspective view of the extruded and coated base materialdeparting the application station/system with the hydrophilic polymericmaterial(s) applied thereto.

FIG. 15 is a perspective view of the pressure applicator system applyingpressure, typically finger pressure, to the loose dry hydrophilicpolymeric material(s) to place the loose dry hydrophilic polymericmaterial(s) into frictional engagement with the base material.

FIG. 16 is a perspective view of the vacuum removal system andguillotine cutting system to make predetermined sized temporary toothrepair composition segments in multiple lines simultaneously, in thiscase, two lines.

FIG. 17 is a perspective view of the cut and sized temporary toothrepair composition segments traveling along a conveyor belt system to bepackaged for use and delivery to the end user. Typically, the devicesare packaged in individual tamper evident segments. A plurality ofsegments may be formed and spaced apart using the same system.Typically, two rows are run side by side, but conceivably any number ofrows could be produced if the systems are elongated.

FIG. 18 is a perspective view of an overall system of the presentdisclosure having two lines of temporary tooth repair compositions beingproduced simultaneously.

FIG. 19 is a perspective view of an overall assembly system for theproduction of the temporary tooth repair compositions of the presentdisclosure having the bottom heat sealing film base rolls of materialand the dimplier systems of the overall systems of the presentdisclosure.

FIG. 19A is a portion of the top film used in the formation of theoverall products of the present disclosure that has been through adimpling process, but not yet placed over the tooth compositions of thepresent disclosure and heat sealed in individual pockets produced by thedimplier(s) of the present disclosure.

FIG. 20 is an enlarged view of a dimplier system of the presentdisclosure showing the top material, typically a clear top material toallow visualization of the product within the dimpled portion of thesealed system.

FIG. 21 is a top view of a set of four conjoined single, hygienicallypackaged products.

DETAILED DESCRIPTION

For purposes of description herein, the terms “upper,” “lower,” “right,”“left,” “rear,” “front,” “vertical,” “horizontal,” and derivativesthereof shall relate to the invention as oriented in FIGS. 1A-1C.However, it is to be understood that the invention may assume variousalternative orientations, except where expressly specified to thecontrary. It is also to be understood that the specific devices andprocesses illustrated in the attached drawings, and described in thefollowing specification are simply exemplary embodiments of theinventive concepts defined in the appended claims. Hence, specificdimensions and other physical characteristics relating to theembodiments disclosed herein are not to be considered as limiting,unless the claims expressly state otherwise.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range, and any other stated or intervening value in thatstated range, is encompassed within the scope of the present disclosure.The upper and lower limits of these smaller ranges may independently beincluded in the smaller ranges, and are also encompassed within thescope of the present disclosure, subject to any specifically excludedlimit in the stated range. Where the stated range includes one or bothof the limits, ranges excluding either or both of those included limitsare also included in the scope of the present disclosure.

It will be understood by one having ordinary skill in the art thatconstruction of the described invention and other components is notlimited to any specific material. Other exemplary embodiments of theinvention disclosed herein may be formed from a wide variety ofmaterials, unless described otherwise herein.

For purposes of this disclosure, the term “coupled” (in all of itsforms, couple, coupling, coupled, etc.) generally means the joining oftwo components (electrical or mechanical) directly or indirectly to oneanother. Such joining may be stationary in nature or movable in nature.Such joining may be achieved with the two components (electrical ormechanical) and any additional intermediate members being integrallyformed as a single unitary body with one another or with the twocomponents. Such joining may be permanent in nature or may be removableor releasable in nature unless otherwise stated.

It is also important to note that the construction and arrangement ofthe elements of the invention as shown in the exemplary embodiments isillustrative only. Although only a few embodiments of the presentinnovations have been described in detail in this disclosure, thoseskilled in the art who review this disclosure will readily appreciatethat many modifications are possible (e.g., variations in sizes,dimensions, structures, shapes and proportions of the various elements,values of parameters, mounting arrangements, use of materials, colors,orientations, etc.) without materially departing from the novelteachings and advantages of the subject matter recited. For example,elements shown as integrally formed may be constructed of multiple partsor elements shown as multiple parts may be integrally formed, theoperation of the interfaces may be reversed or otherwise varied, thelength or width of the structures and/or members or connector or otherelements of the system may be varied, the nature or number of adjustmentpositions provided between the elements may be varied. It should benoted that the elements and/or assemblies of the system may beconstructed from any of a wide variety of materials that providesufficient strength or durability, in any of a wide variety of colors,textures, and combinations. Accordingly, all such modifications areintended to be included within the scope of the present innovations.Other substitutions, modifications, changes, and omissions may be madein the design, operating conditions, and arrangement of the desired andother exemplary embodiments without departing from the spirit of thepresent innovations.

The dental compositions, including the extrudable dental cementcompositions and the temporary tooth repair compositions as well as themethods of their use and packaging described in the present disclosuremay comprise, consist of, or consist essentially of the elements of theproducts as described herein, as well as any additional or optionalelement(s) described herein or otherwise useful dental compositions,including dental cement applications and in temporary tooth repair useapplications. Consists essentially of or consisting essentially of meanthat the steps, composition or formulation (a) necessarily includes thelisted ingredients and (b) is open to unlisted ingredients that do notmaterially affect the basic and novel properties of the composition suchas their ability to adhere for many hours after finger pressure isapplied to adhere the tooth repair composition and still allow forfinger force removal of the composition from engagement with the tooth,typically a damaged and/or sensitive tooth at any time. In this case,for example, while potentially some amount of cross-linking catalystcould be added to the pliable material employed for the devices of thepresent disclosure (the pliable material typically but not limited touncured high consistency silicone elastomer base) and not cross-link thepliable material; however, if an amount of cross-linking catalyst isincluded in the temporary tooth repair compositions of the presentdisclosure to substantially or completely cross-link or cure the dentalcompositions, they materially change the functioning of the compositionbecause its shape is no longer permanently adjustable. Similarly, if anadhesive or adhesives or other non-adhesive component(s) are used inconnection with the dental compositions of the present disclosure thatwill not permit the dental, typically the temporary tooth repaircomposition to adhere for an extended period of time, but also beremovable using finger pressure, then this would materially change thefunctioning of the composition of the present disclosure.

To the extent that the term “includes” or “including” is used in thespecification or the claims, it is intended to be inclusive in a mannersimilar to the term “comprising” as that term is interpreted whenemployed as a transitional word in a claim. Furthermore, to the extentthat the term “or” is employed (e.g., A or B) it is intended to mean “Aor B or both.” When the Applicant intends to indicate “only A or B butnot both” then the term “only A or B but not both” will be employed.Thus, use of the term “or” herein is the inclusive, and not theexclusive use. Also, to the extent that the terms “in” or “into” areused in the specification or the claims, it is intended to additionallymean “on” or “onto.”

Also, as discussed herein tooth means a single tooth and teeth meansmore than one tooth, but the concepts of the present disclosure and thecomposites, systems and other disclosed materials of the presentdisclosure may apply to one or more teeth unless specifically indicatedotherwise herein.

As shown in general in FIGS. 1A-1C, the present disclosure is generallydirected toward temporary tooth repair compositions, typically a humantemporary tooth repair composition 10, and methods of using thetemporary tooth repair compositions by a non-dental professional or adental professional to temporarily repair a broken tooth and cover anyexposed dentinal tubules that allow for access to nerve(s) that may becausing the person pain until the person can receive more permanent carefrom a dental or medical professional. A person with a broken or damagedtooth or teeth with or without an exposed dentinal tubule(s) mayexperience pain when a tooth breaks or a crown is broken on a previouslyrepaired tooth. The person with a damaged tooth or teeth may also not beexperiencing pain but simply want to yield an aesthetically pleasingappearance during the aforementioned interval or create a smooth surfaceon the tooth until further, more permanent dental care can be obtained.The temporary tooth repair compositions of the present disclosure arealso able to be used to smooth out rough surfaces on a damaged tooththat may not cause pain but are felt by the person with the tooth orteeth with a rough surface or surfaces thereon.

The dental compositions, which are typically dental compositions for (a)treating sensitive teeth or delivering an active ingredient to a toothexterior or exposed interior surface and/or (b) a temporary tooth repaircompositions 10 of the present disclosure employ an uncured(uncrosslinked) silicone high consistency rubber base and one or morepigments acceptable for the buccal cavity, typically metal oxidepigments to match the color of the temporary tooth repair compositionwith the color of a typical natural tooth or may be color matched to theparticular tooth color of the wearer as well by selecting an appropriatetint of white color. Most often the white color is a Vita Shade Range ofA2-D2. The uncured (uncrosslinked) silicone high consistency rubber baseemployed is safe for the oral environment, more pliable and is fingerpliable and shapeable than previously known compositions. The dentalcompositions of the present disclosure are comfortable to wear on thetooth or teeth as a temporary tooth repair composition, and has superiortensile strength. Additionally, the uncured (uncrosslinked) siliconehigh consistency rubber base employed is more than 18 times more pliablecompared to traditional orthodontic relief wax, based on tensile testingper ASTM D412 guidance. Additionally, the uncured (uncrosslinked)silicone high consistency rubber base employed is more than 16 timesmore transmitting of visible light compared to traditional orthodonticrelief wax, based on testing performed using a dual-beam Hitachi U-2910UV-Vis spectrometer, making it a clearer base material for subsequentpigmentation to achieve desired tooth color(s).

As shown in the figures, when used as the temporary tooth repaircomposition, the dental compositions 10 of the present disclosure areeasily placed into engagement with a damaged tooth (See FIG. 1A) and maybe molded in place by a layperson/user (in situ) with just fingers orwith fingers and the opposing tooth above or below the damaged tooth toachieve a tooth shaped facsimile (See FIG. 1B) and results in theappearance of a complete tooth where the damaged tooth portion ismissing from the tooth being chipped (See FIG. 1C). No applicator toolor other tool is necessary for use of the dental compositions of thepresent disclosure. The dental compositions of the present disclosuretypically are tooth colored and not cement based, which avoids thedifficult removal of hardened material. They are also non-toxic andnon-allergenic, adhere within seconds, typically within 10 seconds, 8seconds or 5 seconds of finger pressure being applied to the compositionwhen placed on the tooth with the adhesive containing surface on thetooth. The compositions of the present disclosure also stay in place formany hours, typically at least 4-8 hours, but up to 24 hours or even aslong as 48 hours while in use.

Typically, as shown in FIGS. 1A-1C, the temporary tooth repaircomposition 10 creates a temporary tooth having generally the same lookand appearance of an undamaged tooth and is engaged with a damagedsurface 14 of a tooth or conceivably teeth. The compositions of thepresent disclosure may also be used to temporarily fill a missingfilling that has fallen out of a cavity that may or may not expose adentinal tubule or have accompanying pain because of the exposed toothtissue being pressure or temperature or airflow sensitive. The dentalcompositions may also be used to temporarily smooth a chipped or jaggedtooth that may irritate the tongue. The compositions of the presentdisclosure also may be used to adhere a crown or cap that has fallen offthe tooth it was placed upon or as a complete temporary replacement forthe cap/crown. In the case of the composition as a way to engage thecap/crown to the tooth it has fallen away from, the cap or crown is dryand a non-adhesive side of the dental composition of the presentdisclosure pushed into the bottom/tooth facing surface of the crown. Thedry interior of the crown adheres to a non-adhesivecontaining/non-powder coated side of the composition pushed intoengagement with the crown by the user. Next, an adhesive side/powdercoated side of the composition of the present disclosure that remainsexposed may be placed onto the wet portion of the tooth that remainsafter the crown fell off and the powder coated adhesive side adheres thecomposition and crown to the exposed tooth surface. No drying of thetooth surface that is exposed after the crown falls off, which can beseverely painful, is necessary and may be avoided as a step entirely.The dental compositions of the present disclosure provide virtuallyinstant pain relief by covering exposed dentinal tubules and sensitivetissues of the broken tooth or lost cap or filling (the siliconematerial provides an occlusive covering). The compositions of thepresent disclosure, as discussed herein are easy to apply and unlikeprior cement composition set within seconds and not hours as is typicalwith traditionally used cement-based compositions. The dentalcompositions of the present disclosure are also typically tooth coloredto repair and hide the repaired damaged tooth from visual attention fromthird parties. The compositions also typically have no bad taste, whichis an often complained about effect of the cement-based tooth repaircompositions. Also, significantly, the compositions of the presentdisclosure can be adhered quickly and one does not have to wait hours toeat or drink, but instead can immediately do so after the composition isapplied. Also, the compositions of the present disclosure are non-toxicif swallowed and latex free, and they do not shed pieces that temporarycements often do. The compositions of the present disclosure are alsopackaged in hygienic single use packaging and require no special toolsfor application.

The devices/compositions of the present disclosure are not cured, butare purposefully finger pliable without the use of tools and shaped withfingers and/or optionally with the use of small implements such as ashaping stick or applicator, which can be made from wood, plastic ormetal. The devices of the present disclosure typically yield one ormore, but typically all of the following novel results:

(1) The devices are not cement based and are easily moldable andshapeable into a satisfactory tooth shape by both trained professionalorthodontic staff and by untrained patients.

(2) The devices stay in place for extended period of time, typically atleast about 4 hours, more typically at least 8 hours and most typicallyat least 12 hours after the 10 seconds or less of finger pressure isapplied to adhere the composition to the tooth or teeth, typically asingle tooth.

(3) The devices of the present disclosure do not “cure”. Unlike the caseof the cement-based materials, the dental compositions of the presentdisclosure do not need to cure prior to eating or drinking. Moresignificantly, if there is any error whatsoever, since the systemspreviously employed are cured, it is hard to redo the process. In thatcase, the cement would need to be removed, which is very difficult andthe entire process repeated, a fact acknowledged in the explicitinstructions of the prior used products, which requires the process tostart over and is why the procedure using cement is best done by anexperienced professional. The material of the present disclosuretypically never cures during the period of time the dental compositionis in use and more typically never cures, giving an opportunity for aninfinite number of corrections to the shaped, if necessary, over anyperiod of time to get the shape right.

As shown in FIG. 2 , the material of the present disclosure the uncured(uncrosslinked) silicone high consistency rubber (HCR) base material 30,is coated on at least one, but typically not all and most typically oneside of the cuboid-shaped uncured (uncrosslinked) silicone highconsistency rubber (HCR) base material 30. The material is extruded inelongated bars 32 of material and subsequently coated thereon with drypowder adhesive. The bars of material are typically produced in acontinuous process and cut into cuboids 34, often cubes prior to finalpackaging. The uncured (uncrosslinked) silicone high consistency rubberbase material may include one or more colorants, typically metaloxide(s) to enable the dental compositions to more accurately match thecolor of the tooth or teeth of the wearer, which is typically a personbut could be any animal (typically a mammal) with teeth.

Uncured (uncrosslinked) silicone high consistency rubber (HCR) basematerial is a blend of one or more silicones with untreated and/ortreated silica filler. The uncured (uncrosslinked) silicone highconsistency rubber base material incorporates proprietary silicones,proprietary amounts of silica filler and proprietary treated silicafiller with proprietary material characteristics. In the industry, thisinformation is kept a trade secret. An “uncured (uncrosslinked) siliconehigh consistency rubber base material” is a known category of siliconematerials to chemists familiar with silicone polymers and/or siliconematerials. Regarding the uncured (uncrosslinked) silicone HCR basematerial, many companies market uncured (uncrosslinked) silicone HCRbase that could be used to prepare composites of the present disclosure,including but not limited to: Wacker ELASTOSIL® R PLUS 4000/50; WackerELASTOSIL® R 401/50 S; Wacker ELASTOSIL® R PLUS 4305/70; WackerELASTOSIL® R PLUS 4305/60; Wacker ELASTOSIL® R plus 4305/80; WackerELASTOSIL® R 401/80S; Nusil MED-2174; Nusil MED-4174; Hoshine HS-525350; DuPont Liveo Q7-4535 Medical Grade ETR Elastomer; DuPont LiveoQ7-4550 Medical Grade ETR Elastomer; DuPont Liveo Class VI Elastomers,and DuPont Liveo Q7-4565 Medical Grade ETR Elastomer. Suitable basematerial may also be prepared with high viscosity polydimethylsiloxane,and/or vinyl-functionalized polydimethylsiloxane, and/orsilanol-functionalized polydimethylsiloxane, and/or Si—H functionalsilicone combined with fumed silica or trimethylsilylated silica filler.An additional class of suitable pliable materials are hydrocarbon-basedwaxes such as paraffin wax, bees wax, and other waxes traditionally usedin the buccal cavity.

Regarding the metal oxide pigments used to obtain a color match of thesilicone HCR base material to one of the VITA Classical Shade Guidecolors, many companies market food grade metal oxide pigments that couldbe used to prepare the inventive dental material, including but notlimited to, white titanium dioxide, brown iron oxide blend, and yellowiron oxide from Sensient Pharmaceutical. In the case of the compositionsof the present disclosure, it is significant that through the propercombination of pigments, it is possible to obtain an uncured dentalmaterial in any of the 16 VITA shades. The VITA shades are one universalway to determine the color of a human tooth. The VITA classical A1-D4shade guide serves to accurately determine tooth shade. The arrangementof the shades in the VITA classical family of shades is as follows:A1-A4 (reddish-brownish); B1-B4 (reddish-yellowish); C1-C4 (greyishshades); and D2-D4 (reddish-grey).

Additionally, a variety of immediate and time released flavorants suchas mint flavorants, cinnamon or cinnamon flavorants, citrus flavors mayalso be employed. Time released flavorants are particularly effectivewhen the dental composition is worn for many hours or days and up toabout 2 weeks. Having a fresher taste is advantageous. Additionally, thedental compositions of the present disclosure may include one or morepreservatives to limited bacterial growth. In particular, thecomposition may include, but are not limited to any one or a pluralityof the following: benzoic acid and salts thereof, sorbic acid and saltsthereof, and parabens. Moreover, the components applied to the exteriorsurface(s) of the dental compositions of the present disclosure mayoptionally include an analgesic (for example, benzocaine) orantibacterial composition or any dry powder, water soluble activeingredient appropriate for delivery to the buccal cavity, includingenamel strengthening ingredients such as sodium fluoride, stannousfluoride, calcium salts, and phosphate salts, and hypersensitivitydesensitization ingredients such as potassium nitrate, strontiumchloride, strontium acetate, stannous fluoride, dipotassium oxalate, andcalcium salts (with or without arginine). The dental compositions of thepresent disclosure are often used after damage to a tooth (including anydamage to the enamel which exposes dentinal tubules) or other mouthinjury occurs. Employing one or more analgesic and/or one or moreantibacterial composition and/or any enamel strengthening ingredientand/or any hypersensitivity desensitization ingredient such as thosediscussed herein may help with the injury site pain and may help preventinfection at the site as well. The analgesic releases over time whenblended with the dry adhesive and other components of the coatingcomposition applied to the surface of the uncured (uncrosslinked) highconsistency rubber base material. Exemplary analgesics that may be usedalone or in combination in the dental compositions of the presentdisclosure include: benzocaine; an NSAID such as ibuprofen;acetaminophen; and acetyl salicylic acid. Exemplary antibiotics that maybe employed alone or in combination in dental compositions of thepresent disclosure include, but are not limited to, erythromycin,clarithromycin and azithromycin. Some of the distinct advantages of thedevices of the present disclosure as a delivery method of any of theabove active ingredients over other delivery methods of the above activeingredients such as toothpastes, mouth washes/rinses, chewing gums andlozenges are: (1) The inventive device targets/delivers the activeingredient(s) to the effected tooth as opposed to the entire buccalcavity; (2) the occlusive and hydrophobic nature of the silicone portionof the inventive device that delivers the active ingredient(s) to thethin film of saliva that coats the tooth and prevents their dissolutionand dilution by additional saliva thereby maintaining an efficaciousconcentration at the tooth such that they perform their function inreduced time (functions such as deadening nerves and occluding dentinaltubules via precipitation), and (3) in the case of hypersensitivity,offers instant occlusion of exposed dentinal tubules while worn toprovide instant relief from hypersensitivity, and extended occlusion ofexposed dentinal tubules and extended relief from hypersensitivity whenremoved. The use of the combination of stannous fluoride, which createsocclusion of exposed dentinal tubules and provides relief fromhypersensitivity by physically blocking the exposed dentinal tubules,and potassium nitrate, which provides relief from hypersensitivity bydeadening the nerves, together, as discussed above, are often used inthe context of the compositions of the present disclosure. Due to thefact that the devices of the present disclosure prevent dilution bysaliva of the components/active ingredients, it has been surprisinglydiscovered that less of these components/active ingredients than wouldtypically be needed to be effect may be used while still maintainingefficacy of the treatment of exposed dentinal tubules. Moreover, unliketoothpastes marketed for sensitive teeth or any aqueous or glycerinbased composition, the compositions of the present disclosure typicallyinclude both potassium nitrate and stannous fluoride over the entireshelf life of the product. The potassium nitrate and stannous fluoride,when included in the coating compositions of the present disclosure aretypically in stable, solid form, typically a dry powder form without anyadded water. These two components cannot be combined in a toothpastemarketed for sensitive teeth because they react with one another toshorten shelf life to unacceptable levels. In toothpaste marketed forsensitive teeth, potassium nitrate individually and stannous fluorideindividually are used in an amount of 0.454% by weight volume of thetoothpaste. In the context of the compositions of the presentdisclosure, the two components are typically combined and stable andpresent in an amount of up to about 5 percent by weight of the coatingcomposition, more typically in an amount of from about 0.01 by weight toabout 5 percent by weight of the coating compositions of the presentdisclosure. However, it has been surprisingly discovered that not onlycan these two chemicals that decrease tooth sensitivity in differentways be used, but they can be used in drastically lower amounts as welland be more effective due to their extended application period directlyto the surface of the tooth and the shielding from dilution byadditional saliva from the buccal cavity during use. Accordingly, thecompositions of the present disclosure may use and most typically do useless of each of these components and, while the components may be usedindividually, they are typically both employed. Most typically both thestannous fluoride and the potassium nitrate are present in an amount ofabout 0.15 percent by weight to about 0.5 by weight percent of thecoating compositions of the present disclosure.

According to an aspect of the present disclosure, the dental compositionof the present disclosure was prepared by combining metal oxidepigment(s) with uncured (uncrosslinked) silicone HCR base (DUPONT®LIVEO®. Q7-4550) on a two-roll mill. Other mixing technologies thatcould be used include, but are not limited to, a sigma blade (“Z-blade”)mixer and a double planetary mixer equipped with high viscosity bladesor a SPEEDMIXER™, which is a double rotation of the mixing cup that issometimes referred to as a dual asymmetric centrifuge. The combinationof centrifugal forces acting on different levels in such a deviceenables very rapid mixing. Batches ranging up to 25 pounds were preparedusing a two-roll mill. The following example illustrates the pigmentcompositions required to achieve inventive dental material of VITA™Shade D2 as established by visual comparison to a reference and by colormapping using camera input analyzed using SHADEWAVE™ Dental ShadeMatching Software (shadewave.com).

Example dental composition VITA™ Shade D2 below.

% titanium % brown iron % yellow iron Example % Q7-4550 dioxide oxideblend oxide VITA ™ Shade 99.964 0.0312 0.0012 0.0039 D2

The amount of uncured, uncrosslinked silicone high consistency rubberbase (Q7-4550, for example) typically ranges in amounts by weight offrom about 99.90 to about 99.99 weight percent of the dentalcomposition, more typically from about 99.92 to about 99.98 weightpercent of the dental composition. The amount of titanium dioxidetypically ranges from about 0.020 to about 0.055 weight percent, moretypically from about 0.030 to about 0.045 weight percent of the dentalcomposition. The compositions of the present disclosure typicallyinclude one or a plurality of different iron oxides to adjust the colorof the dental to any appropriate VITA shade to match the person's othernatural or artificial teeth color. For example, a first iron oxide and asecond iron oxide may be employed. A third iron oxide or any number ofsubsequent iron oxides may be employed as well. Typically, the ironoxides employed are brown iron oxide and yellow iron oxide. The amountof brown iron oxide blend typically ranges from about 0.0005 to about0.015, more typically from about 0.001 to about 0.010 weight percent ofthe dental composition. The amount of yellow iron oxide typically rangesfrom about 0.002 to about 0.006, more typically from about 0.0030 toabout 0.0050 weight percent of the dental composition. The resultingdental material may be rolled into sheets or extruded into rods or intopre-cut small pieces as possible modes of marketing. Red iron oxidepigment may also be used in combination with the above pigments toobtain a VITA Shade match. The materials are typically mixed togetherthoroughly at room temperature, a temperature of from about 65 degreesFahrenheit to about 80 degrees Fahrenheit, but the temperature of themixing is not presently believed to be critical.

An additional benefit of the dental compositions of the presentdisclosure is the ability to adjust opacity from being completely opaqueto translucent depending on the amount of titanium dioxide pigment andthe thickness of the inventive dental material. For example, the aboveexample is opaque at a thickness of 3 mm, mostly opaque at a thicknessof 2.5 mm, and somewhat translucent at a thickness of 2 mm or less.Natural teeth often progress from opaque to somewhat translucent as oneprogresses from the cervical to the incisal edge. The inventive dentalmaterial allows one to mimic this behavior by varying the amount oftitanium dioxide pigment in the material and/or the thickness of thematerial once placed into engagement with the tooth or teeth.

The dental compositions of the present disclosure typically have the dryadhesive gravity deposited, dusted, sprayed or otherwise applied to onesurface therefore. Applying, which is typically done by gravitydepositing the dry powdered hydrophilic polymeric substance and anyother dry silicone adherable material thereto onto the malleablehydrophobic material, and may be accompanied by may be accomplished by avariety of mechanical means, either separately or in combination, andinclude a press, a roller, rods, a blade, all of which make contact withthe surface of the malleable hydrophobic material to which the powderedhydrophilic polymeric substance has been deposited. Removing loose drypowdered hydrophilic substance that does not adhere to or is notimpregnated into the surface of the malleable hydrophobic material maybe accomplished by shaking, brushing, air pressure, an ion air knife, orvacuum. Alternatively, upon contact of the dry powdered hydrophilicsubstance with one or more surfaces of the malleable hydrophobicmaterial, no rubbing or pushing of the dry powdered hydrophilicsubstance may be done, and no removal of loose dry powdered hydrophilicsubstance may be done, and the dental composition used “as is”.

Suitable malleable hydrophobic materials that may be used in the contextof the present disclosure include, but are not limited to: Orthodonticrelief Wax (a product consisting of one or more hydrocarbon-based waxesthat may also include inorganic and/or organic fillers); uncured(uncrosslinked) silicone high consistency rubber (HCR) base material,which as discussed above is a blend of one or more silicones withuntreated and/or treated silica filler, or any hydrophobic waterinsoluble solid material that is malleable at 37° C. or lower and safefor the human oral environment. The uncured (uncrosslinked) siliconehigh consistency rubber base material incorporates proprietarysilicones, proprietary amounts of silica filler or treated silica fillerpossessing proprietary material characteristics. In the industry, thisinformation is kept a trade secret. An “uncured (uncrosslinked) siliconehigh consistency rubber base material” is a known category of siliconematerials to chemists familiar with silicone polymers and/or siliconematerials. Regarding the uncured (uncrosslinked) silicone HCR basematerial, many companies market uncured (uncrosslinked) silicone highconsistency rubber base that could be used for inventions of the presentdisclosure. These include but are not limited to: Wacker ELASTOSIL® RPLUS 4000/50; Wacker ELASTOSIL® R 401/50 S; Wacker ELASTOSIL® R PLUS4305/70; Wacker ELASTOSIL® R PLUS 4305/60; Wacker ELASTOSIL® R plus4305/80; Wacker ELASTOSIL® R 401/80 S; NUSIL™ MED-2174; NUSIL™ MED-4174;Dow Corning SILASTIC® Q7-4535 Medical Grade ETR Elastomer; DUPONT®LIVEO® Q7-4550 Medical Grade ETR Elastomer; DUPONT® LIVEO® Q7-4565Medical Grade ETR Elastomer, DUPONT® LIVEO® Class VI Elastomers, andHOSHINE® HS-1552PT High Transparency Extrusion Silicone Rubber. Themalleable hydrophobic material may be extruded or otherwise formed byshaping the material. Other ways of forming the base, malleable,hydrophobic material into a shaped base include, but are not limited to,using a mechanical flat press or a roller press to produce flat sheetsthat are then coated with the dry powdered hydrophilic polymericsubstance(s) and cut into pieces, or pressing the base, malleable,hydrophobic material into a mold, then opening the mold and removing theshaped pieces, which would thereafter be coated with the dry powderedhydrophilic polymeric substance(s) and optionally cut into smallerpieces or shaped, or the powdered hydrophilic polymeric substance(s)could be directly deposited (dusted) onto the mold surfaces as a moldrelease agent, ending up incorporated onto the surface of the moldedpiece.

Suitable dry powdered hydrophilic polymeric substances are those thatcan serve as moisture activated pressure sensitive adhesives and absorbwater and are substantially soluble in water. These include, but are notlimited to, any material from a list comprising: polyvinylpyrrolidones(PVPs), polyoxazolines, polyethylene glycols, starches, polyacrylicacids, carbomers, polyvinyl alcohols, polyvinyl acetates, cellulosederivatives, polysaccharides (such as xanthan gum, pectin, guar gum,starches, cellulose ethers, chitosan derivatives), polyacrylamides,N-vinyl caprolactam polymers, and copolymers of methyl vinyl ether andmaleic anhydride (PVM/MA), and other water-soluble polymeric adhesivesor blends of any of the above or other water-soluble polymericadhesives, including, but not limited to, TICALOSE® CMC 15 Fine,TICALOID® 750, SALADIZER® 210, TICAGEL® Gellan HS, TICA-ALGIN® 400,METHOCEL® HPMC K100M, Locust Bean Gum POR/A2, METHOCEL® K100M PremiumHPMC DC2, ASHLAND™ NATROSOL™ 250HHW Pharm, INGREDION® pre-hydratedPectin 1400, LUBRIZOL® CARBOPOL® 971P NF Polymer, LUBRIZOL® CARBOPOL®974P NF Polymer, LUBRIZOL® NOVEON® AA-1 Polycarbophil USP, and mixturesof two or more of any of the above.

The water-soluble polymeric adhesive(s) are safe for use in the buccalcavity of a human. One particular polyvinylpyrrolidone that may be usedis PLASDONE® K-29/32 polymer, which is a stable, water-solublepolyvinylpyrrolidone that meets U.S., European and Japanesepharmacopoeia specifications for povidone. One particular polysaccharidethat has been found to be effective is xanthan gum as the only or themajority dry powder adhesive of the coating powder portion of the dentalcompositions of the present application. It is currently believed thatpre-hydrated guar gum powder that has been further hydrated beyond thelevel when commercial purchased performs surprisingly better as anadhesive powder than other dry powders used whereas the use ofcommercially available pre-hydrated guar gum 8/22 powder fromINGREDION®, for example, does not work as well. The level of hydrationis believed to be a surprisingly significant factor in theimplementation of guar gum as a dry adhesive powder. The use of guar gumas a superior dry adhesive appears to be dependent on the hydrationlevel of the guar gum prior to its application as a “dry” ingredient. Inthe context of the present application a “dry” ingredient does not meanthat the component is devoid of any water molecules, but rather that itis capable of being dusted onto a surface of the extruded substrate,which is typically the uncured (uncrosslinked) high consistency siliconrubber. In the context of the pre-hydrated guar gum 8/22 powder productfrom INGREDION® the moisture level of the purchased/supplied product isreported to be from 0% to 12%. It is presently believed the higherlevels of hydration than 12% while maintaining a dry powder dustablephysical form surprisingly produces superior adhesiveness qualities.Xanthan gum, for example, has a viscosity of 3300 cP in a 1% aqueous gelsolution whereas a hydrated above 12% guar gum was tested to have aviscosity of 5300 cP in a 1% aqueous gel solution.

The adhesiveness of various adhesive powders has also been tested. Toconduct these tests, first, Dupont Liveo Q7-4550 high consistencysilicone base was extruded through a 3 mm×6 mm rectangular die using aram extruder and cut into 6 mm lengths (herein referred to as “samples”)for trials. The samples were coated with adhesive polymer powder viarolling by hand in the powder and then transferred with forceps into aclean plastic weigh boat and gently shaken for five seconds to removeexcess powder. Samples were then placed on the end of a rotating (50rpm) shaft while a fine mist of water was applied to the sample for 20seconds (mist produced using pressurized water and a Spray Systems1/4LNN-SS1 spray nozzle). The wetted sample was removed from therotating spindle via forceps and placed on a texture analyzer stage(lower test surface of a Brookfield CT3 texture Analyzer). The uppertest surface was a translucent 25.4 mm diameter acrylic cylindricalprobe having a completely smooth surface connected to a 25,000 gm loadcell. A compression test cycle was chosen to closely approximate thepressing of a sample onto a tooth, with a trigger load set-point beingreached upon contact of the upper test surface with the sample. Theinstrument then continued to flatten the sample until a target distanceset point was reached. After a set hold time of 5 seconds once thesample was flattened, the upper probe was pulled away from the sample ata rate of 0.3 mm/s. Adhesiveness (mJ) was measured and is the totalamount of work done during the process of pulling the upper probe awayfrom the flattened sample. Polysaccharides were demonstrated to be thebest dry powders to be used as adhesives in the context of the dentalcompositions of the present disclosure; however, this is not the onlyfactor to be considered. The adhesive tests showed the following:

Adhesive Powder Adhesiveness (Work to Remove in mJ) Guar Gum 1.18POLIGRIP ® 1.02 Xanthan Gum 0.92 Polyvinylpyrrolidone (PVP) 0.53POLYGRIP® is an over the counter adhesive that consists of twoingredients: carboxymethyl cellulose (CMC) and polyvinyl methylether/maleic acid (PVM/MA).

The average duration of adherence with different adhesive powders wastested by first applying by shaking the dust of the adhesive powder tobe tested onto the surface of the base material, the uncured(uncrosslinked) silicon base. Next, the excess powder was shaken off,and the devices were applied to wet with saliva second bicuspids (secondpremolars) upper teeth #4 and #13 and worn overnight. Test results areaverages of multiple measurements and indicate how long the devicestayed attached until it fell off. Longer durations than those shown inthe table are achieved and depend on which teeth are used for testing.

Adhesive Average Duration Poligrip Super Denture Adhesive Powder 2.75 hr(max 3 hr) Vanderbilt Minerals VanzanNF xanthan Gum 3.6 hr (max 4 hr)Ingredion pre-hydrated GuarNT 8/22 having 7.2 hr (max 9 hr) additionalhydration such that it is above 12% water but remaining a dust/powderfor application

Another aspect used to evaluate the effectiveness of different adhesivepowders is adhesive tack. Tack is a measure of how quickly an adhesivebond is formed when two surfaces are brought together. The faster twosurfaces bond, the higher the tack. Good adhesive tack is important forthe dental composition of the present disclosure as it helps the devicesto grab hold and keep from sliding off during application. Thecompositions of the present disclosure improve tack at least two ways.First, a polysaccharide gum such has xanthan gum and pre-hydrated guargum with extra hydration above 12% may be employed. Second, the size ofthe adhesive powder particles is believed to be important. The smallerparticles of the powdered adhesive also appear to be a factor and thesmaller particles are believed to work better than others due to theirhigher surface area and ability to wet and form sticky gel faster,thereby providing good tack. Smaller particles can however also getpushed (buried) into the soft silicone upon application of the device tothe tooth, hiding them from saliva, which is negative impact for tack.The pre-hydrated guar gum having a hydration in excess of 12% water isbelieved to surprisingly have small particle size, but the particlesclump together to make large clusters, which resist being buried andinaccessible to activation by saliva and use by the composition toadhere to a surface of the tooth or teeth.

Additionally, as discussed above and herein, one or more dry powderedflavor substances may be added to the hydrophilic polymeric substancesmentioned above to yield a flavor sensation to those using the devicesupon application to teeth that are wet with saliva. In addition, watersoluble (to any extent) compounds that produce a variety of benefits totooth enamel and oral health in general can be included and mixed withthe dry powdered hydrophilic polymeric substance and be delivered in aneffective amount and manner over a treatment effective period of time.One or more such compounds may be used. While not typically used in thetemporary tooth repair dental compositions of the present disclosureused to repair lost fillings, disengaged caps or crowns and/or chippedor broken teeth, some of the treatment or benefit inducing compoundsthat can be included into in a mixture with the dry powdered hydrophilicsubstance(s) to form the mixture that is applied to a surface of themalleable hydrophobic material include, but are not limited to, thefollowing: sodium fluoride, stannous fluoride, acidulated phosphatefluoride, sodium monofluorophosphate, calcium sulfate, calcium acetate,calcium lactate (with or without addition of xylitol, the combinationremineralizes tooth enamel), calcium phosphate, amorphous calciumphosphate complexed with casein phosphopeptides, tricalcium phosphatethat has been mechanochemical ball milled with fumaric acid, calciumsulfate, sodium phosphate, potassium phosphate, dipotassium phosphate,and others. Calcium salts and phosphate salts with or without fluorideor carbonate salts may be used. Materials such as calcium chloride,sodium phosphate and sodium fluoride may be placed into non-aqueousmediums and, when they come into contact with saliva, for example, arethen re-precipitated as amorphous calcium phosphate, amorphous calciumphosphate fluoride, amorphous calcium carbonate phosphate or amorphouscalcium carbonate phosphate fluoride for remineralization of the teeth.The remineralization is further aided by the extended time the compositewith the treatment material/components contained therein are applied tothe teeth in the context of the present disclosure and their positioningdirectly around, adjacent and over the braces, which are particularlocations where demineralization often occurs when braces are worn. Thearea around the orthodontic device is particularly treated. In addition,any of the above combination of benefit inducing compounds that lead toprecipitate formation in exposed dentinal tubules may be employed fortreatment of dentin hypersensitivity.

In particular, it has been discovered that compounds used to reducesensitivity of teeth may be applied to the enamel of the teeth throughthe application of a dental composition of the present disclosure. Whenthe dental compositions of the present disclosure are used to helpreduce teeth sensitivity, the dental compositions may be applied todamaged or undamaged, but nevertheless sensitive teeth. One or aplurality of different tuble blocking or occluding agents may beemployed as component of the dry powdered ingredients. If used, thetooth or teeth desensitizing agents that block or occlude exposed dentintubules may be blended with the dry powder adhesive as well as any otheroptional dry components to be applied to the surface of the tooth orteeth to form a homogenous blend of dry powder ingredients before it isapplied to at least one surface of the uncured (uncrosslinked) siliconbase material or other finger force malleable hydrophobic material.

The tuble blocking or occluding agent(s) that may be included include,but are not limited to: strontium salts such as strontium chloride andstrontium acetate; Arginine with calcium carbonate (8% by weight calciumcarbonate); calcium sodium phosphosilicate; stannous fluoride; andcombinations thereof. The tuble blocking or occluding agent(s) can beused to occlude or block dentinal tubules, which prevents stimuli fromcausing fluid flow in the tubules of the teeth thereby preventing thenerve endings inside the tooth from being stimulated. Arginine and 8%calcium carbonate (sold under the trade name PRO-ARGIN™) PRO-ARGIN™blocks tubules upon its application by depositing calcium- andphosphate-containing minerals within the dentinal tubules. Both arginineand calcium carbonate (CaCO₃) are required for this action. Arginine isfound naturally in saliva. Arginine may help usher calcium to opentubules for incorporation of calcium phosphate into dentin. Calciumcarbonate creates a basic environment, and calcium phosphate salts areless soluble at higher pH (more basic). The combination of high localcalcium concentration at the dentin tubule at basic pH is designed topromote precipitation of calcium phosphate salts and reduce sensitivity.

Strontium acetate is another tuble blocking or occluding agent that mayoptionally be used in the context of the dental compositions of thepresent disclosure. Unlike the original strontium chloride, strontiumacetate can be formulated into fluoride-containing dentifrices. Upontoothbrushing, strontium-based precipitates form to occlude dentinaltubules and build a resistant barrier over time.

Yet another tuble blocking or occluding agent that helps desensitizeteeth when used in connection with the dental compositions of thepresent disclosure is calcium sodium phosphosilicate)(NOVAMIN®). Insaliva, NOVAMIN® releases calcium and phosphate ions and raises the pH.Under these conditions, calcium phosphate salts precipitate fromsolution to not only block dentin tubules but also to form an insolublecalcium phosphate layer on the surface of enamel.

Additionally, one or more colorants (pigments) that are safe for use inthe buccal cavity may be added to the base material to achieve a fingerforce malleable hydrophobic material of any color.

Conceivably, the present dry powdered hydrophilic polymeric substance(s)alone or, as discussed above, in combination with one or more of any ofthe above-mentioned materials, typically the water-soluble materials maybe mixed or blended together into a mixture/blend, which is typically ahomogenous blend, to be applied to a surface of one or a plurality ofsurfaces of the malleable hydrophobic materials. The dry powderedhydrophilic polymeric substance(s) adheres the overall device to a toothand facilitates delivery of the treatment or tooth benefit material suchas the teeth desensitizing agent(s) to a surface of one or more of thesetooth beneficial materials onto the teeth surfaces or an individualtooth surface and used for delivery of one or more treatmentcompositions or compound types whether or not an orthodontic device ordevices are present. Typically, an orthodontic device such as a bracewill not be present however, but could be present. As with the drypowdered hydrophilic polymeric substance, typically xanthan gum, due tothe water-soluble nature of the materials, they hydrate when applied tothe surface of the tooth or teeth. Also, one could incorporate glycerinand PVP into the base uncured (uncrosslinked) silicone base materialalong with one or a plurality of tuble blocking or occluding agents tohelp reduced sensitivity in teeth, but it is presently believed thiswill be less effective since greater amounts of material would be neededto produce such a dental composition and less tuble blocking oroccluding agent(s) would be brought into engagement with the surface ofthe tooth. Nevertheless, this may be another delivery mechanism forproviding tuble blocking or occluding agent(s) into engagement with asurface or the surfaces of a tooth or teeth to reduce their sensitivity.

DuPont Liveo® Q7-4550 High Consistency Rubber Base may be extrudedthrough a 6 mm×3 mm stainless steel die to produce mostly clear,colorless rectangular rods (See FIG. 2 ). These rods adhere to drysurfaces but totally non-adherent to wet (with water) surfaces. Next,xanthan gum may be applied by dusting (a process of sprinkling the drypowder xanthan gum onto the surface of the rods such that the rods haveat least the upward facing surface substantially or completely coveredwith the dry powder component(s) of the present disclosure, in this casejust the xanthan gum. Excess dry powder may optionally be removed fromthe surfaces of the rod by brushing it off either with a nylon brush orsimply with a finger, resulting in an opaque surface appearance due tothe powder coating that adhered to the rod. As shown in FIG. 2 , piecesof 6 mm length were cut from the rod, resulting in 3 mm×6 mm×6 mm piecesin which the two 6 mm×6 mm faces and two of the 6 mm×3 mm faces may becoated with powdered xanthan gum. When these pieces are applied (pushedon with pressure from a dry finger) to wet teeth in such a manner thatone of the coated surfaces contacted the wet teeth, the piece adhere tothe wet tooth and stay on the tooth for three to eight hours, duringwhich time food and beverages may be consumed. Additionally, the piecein contact with the dry finger will not adhere to the dry finger.Additionally, the same adhesive behavior will be observed if excessxanthan gum is not brushed off before application to the wet tooth.

Excess dry powder xanthan gum beyond what is necessary to adhere thedental composition to the tooth is typically deposited onto a texturedsurface of an extruded rod of base material, the xanthan gum may berubbed into the surface with gentle pressure using a dry finger or theflat surface of a stainless-steel spatula or a smooth or textured metalroller. Excess powder may be removed from the surfaces of the rod bybrushing it off either with a nylon brush or simply with a finger. Theresult of the application of the dry powder onto a surface of theextruded rod of base, finger malleable material is an opaque surfaceappearance due to the powder coating that adhered to the rod and somewhite spots due to xanthan gum-filled depressions on the texturedsurface. The opaque nature of the dry powder surface is advantageousbecause it readily tells a user of the dental compositions of thepresent disclosure which side is the adhesive or adhesive and anotherdry component/active ingredient containing surface.

As shown in FIG. 3 , the method of applying the dry powder adhesivematerial of the present disclosure may utilize a knurled or otherwisetextured roller 40 and a second roller 42 that has a groove/channel 44that receives hydrocarbon wax or silicone-based finger force malleablehydrophobic base material 30. Notably, while it may do so, the knurledor otherwise textured roller does not typically apply a texture to theextruded base material 30. The textured surface is obtained using a dieduring the extrusion process (see FIG. 8 and FIG. 12 ). Instead, theknurled or textured roller utilized the cavities in the roller to holdthe dry powder adhesive material before it is applied. If atexturization is made to the base material, this texturization is doneas the base material is extruded by extruding the base material throughan extrusion die as shown in FIG. 8 . The extrusion die has an about 6mm×about 3 mm shape. The pattern on one surface, the surface to receivethe dry powder adhesive, is a series of microgrooves producingprojections (A) extending from a side of the die and having a maximumdepth of about 0.02 inches, but conceivably the depth could be fromabout 0.4 to about 0.01 inches. The main purpose of the grooves would beto create substantially V-shaped channels within which the dry adhesivematerial (and optionally other dry and also typically water-solublecomponents) may be placed as the extruded rod passes through the overallsystem and the knurled or otherwise textured roller 40 and the secondroller 42. Conceivably, the use of a textured roller 40 is unnecessarywhen the micro-grooved extruded rod of base material is employed, buttypically both are utilized to ensure the dry powder adhesive isdelivered into the microgrooves. As shown in at least FIG. 3 , the tworollers 40, 42 are proximate one another such that the dry powderadhesive material in the textured surface on one side of the basematerial 30 (the optionally micro-grooved side) is delivered intoengagement with the base 30 within the created textured surface 46 or onthe flat unmicrogrooved surface of the extruded rod of base material 30.In FIG. 3 and other figures of this application, the textured surface,which would typically have linear (typically V-shaped) groovesconsistent with the die shown in FIG. 8 , is shown with the adhesivepowder applied in the knurled pattern on the base material. However, thegrooves typically would be present. This creates a continuous productionprocess.

FIG. 4 shows the process for forming the composite material of base 30and powder engaged to a surface of the composite, but shows the systemwithout the powder inserted into the dry powder feed cavity 48 in thepowder guide bracket 50, which is spaced above the textured or knurledroller 40 such that powder is delivered to the grooves of the texturedor knurled portion 46 of the roller 40. The roller 42 may be spacedbelow or adjacent or otherwise in a force receiving engagement with thetextured roller 40. FIG. 5 shows the system with the dry powderparticles 52 generally shown filled into the dry powder feed cavity 48.FIG. 6 shows the system with a third roller 54 on the feed side of thesystem to feed the base material 30 into the knurled or textured roller40. The base material is shown smooth on this side of the system. FIG. 7shows the other side of the system after the powder is applied andtexturizing done to the base material to form the dry powder coatedcomposite orthodontic protection device material 56 of the presentdisclosure.

FIG. 8 shows a cross-sectional view of the die of the extrusion of thepresent disclosure. The die forms a plurality, typically about five (5)or more, of grooves on a length of the rectangular cross-section. Thedie shown in FIG. 8 is one version of an extrusion die opening that isroughly 6 mm (B)×3 mm (D) that has a pattern that would be cut into itusing EDM (Electric Discharge Machining) wire cutting. The die placesmicrogrooves into the surface of the silicone rod. The microgroovesreceive the hydrophilic polymeric substance(s) such as xanthan gum orPVP in powder form when it is deposited onto it. This does two things:First, the microgrooves make the surface that has been powdered moreobvious to the user. Second, the grooves carry additional amounts ofhydrophilic polymeric substance(s) such as xanthan gum or PVP. While notnecessary for adhesion, the added amounts of the hydrophilic polymericsubstance(s) facilitate greater adhesion forces to the surface of thetooth/teeth and/or a surface of a dental appliance or orthodonticdevice. FIG. 8 shows ten grooves, however, fewer or more grooves may beemployed. Typically, ten or fewer, more typically five grooves or fewerare used.

An artificial finger pressure application device 70 as shown in FIGS.9A-9C is typically used during production of the overall orthodonticprotection device is typically used to apply a finger pressure amount offrom 0.2 psi to about 2 psi and force the dry powdered hydrophilicpolymeric material(s) to mechanically adhere to at least one (typicallyone) surface of the extruded base material. The pressure could beslightly more than fingertip pressure of up to about 4 psi as well. Theconstruction of the artificial finger pressure application device 70 isshown in FIGS. 9-11 . The artificial finger pressure application device70 engages the swivel bar 80 using the mounting peg/projection 79, whichis engaged with a receiving aperture 81 in the swivel bar 80. Theartificial finger pressure application device 70 has a housing 72 thatreceives the soft urethane artificial finger 74. The housing has anoutwardly extending peg 76 that extends along the longitudinal axis ofthe artificial finger pressure application device 70 and is removablyand rotatably engaged, typically by hand and without the use of tools,with a recess 82 in the swivel bar 80. The artificial finger pressureapplication device 70 is engaged in the processing line to press the drypowder adhesive into the extruded silicone rod after the knurled wheeldeposits PVP.

FIG. 12 shows a finger force malleable material being extruded to formdry adhesive receiving microgrooves 90 on a top length surface 92 of thebase material 20. Once extruded, the base material 20 proceeds to gounder a guide roller 94 (See FIG. 13 ) and into the larger extruded basematerial receiving roller 42. The grooved base material is fed into thegroove(s)/channel(s) 44. As shown in FIGS. 13-14 , the base materialproceeds such that the dry adhesive and/or other hydrophilic polymericmaterial(s) is applied, typically by gravity at this stage, onto the topsurface of the base material from the knurled portion(s) 46. As shown inFIG. 18 , the dry adhesive, which is typically xanthan gum, and/or otherhydrophilic polymeric material(s) are typically delivered from a funnel104 or other container spaced above the knurled portion(s) such that thedry adhesive and/or other hydrophilic polymeric material(s) aredelivered by gravity through the downspout 102 of the funnel 104 andinto the knurled portion(s) which then deliver the dry adhesive and/orother hydrophilic polymeric material(s) to the base material.

As shown in FIG. 15 , the dry adhesive and/or other hydrophilicpolymeric material(s) coated base material then is guided under theartificial finger pressure application device 70 such that essentially apressure in the amount of finger pressure (about 0.2 to about 2 psi orless). FIG. 16 shows the coated base material proceeding under a rod 96and between two guide posts 98. The rod 96 has a vacuum that removes anyloose and not frictionally engaged hydrophilic polymeric material(s)from a surface of the base material. Typically, hydrophilic polymericmaterial(s), such as xanthan gum, are only applied to one surface tomake that surface the user evident surface to be applied to the surfaceof the tooth/teeth/dental device(s). The vacuum helps remove excesshydrophilic polymeric material(s) from other surfaces the material maybe loosely connected to. Once applied by the end user, as discussedabove, the base material and the hydrophilic polymeric material(s)become essentially clear or visibly clear to the naked eye. FIG. 17shows the cut and sized orthodontic protection devices traveling along aconveyor surface 202 to be packaged for use and delivery to the enduser. Typically, the cuboid dental compositions 200 are thereafterpackaged in individual tamper evident containers.

FIG. 16 also shows the guillotine cutting system 100 that is used to cutthe dental compositions of the present disclosure into a predeterminedsize for each dental composition. Typically, they are in the form of acuboid dental compositions 200 sized to cover at least one toothsurface; however, the devices can be sized to cover a plurality ofteeth. The system typically produces two dental composition cuboids persecond (one cuboid per second from each of two rods), but the systemcould run at a rate as fast as two dental compositions per extruded rodper second utilized instead of one or conceivably at slower speeds aswell. The system may also run at one dental composition per 0.66 secondsper extruded rod. In FIG. 18 , an acrylic clear tube 102 holding the drypowder adhesive and other optional components (the hydrophilic polymericmaterial(s)) is shown. Inside and also attached to the acrylic tubedownspout 102 will be vibrators (not shown) which actuate, typically atprogrammable intervals, to make sure the dry powder (the hydrophilicpolymeric material(s)) shakes down into the applicator. The large whitegrooved TEFLON® 42 roller that holds the extruded rod as it receives dryadhesive powder (the hydrophilic polymeric material(s)) applied(typically dropped) onto it also has an adjustable spring attached tothe device 70, and a white TEFLON® scraper 106 below to help remove theextruded rod from the groove in the TEFLON® roller 42. You can also seetwo tubes hooked to a vacuum cleaner. The knurled steel roller thatfills with dry adhesive powder (the hydrophilic polymeric material(s))and transfers it to the extruded rod can be of various depths to theknurls, which in turn controls how much dry adhesive powder (thehydrophilic polymeric material(s)) gets dumped onto the base material(extruded rods). It is part of a black colored roller, which is blackbecause it has been anodized.

A KEYENCE® vision system or similar vision system is typically used inconnection with the present systems to ensure that a minimum level ofthe hydrophobic water insoluble solid material (typically xanthan gumalone or in combination with one or more of the other substancesdiscussed above) is applied by measuring how white the material isleaving the manufacturing device. If there is not sufficient xanthan gumor other powder material applied to the surface, the vision system willidentify this state and notify the user of the production device(s) tostop the system and/or add more xanthan gum or other hydrophobic waterinsoluble solid material(s) to the applicator or the funnel deliverysystem/hopper so that the hydrophobic water insoluble solid material(s)are available in adequate amounts. Instead of the systems describedabove, a cable coating system such as the NORDSON™ ECC 702 system may beemployed. The applicator uses an electrostatic charge to produce eventpowder coatings and employ a corona process to charge powder particleswith ions from a high voltage source. The powder is fluidized, chargedand sprayed onto the cable. Pumps maintain an adjustable, even flow ofpowder to obtain any desired coating thickness.

As shown in FIGS. 18-20 , a unique packaging system is employed as partof the continuous line. The conveyor surface is actually a bottom layerthermoplastic film of the packaging system of the present disclosure.The film 212 is fed off of rolls 214 and guided around guide rollers 215to bring them underneath the guillotine cutting system where the dentalcompositions of the present disclosure are placed thereon automatically.The film 212 is typically a polyolefin or polyester or a poly-laminatefilm that includes a polyolefin or a polyester as one of the layers. Thedental compositions are then covered and either heat or pressure sealedwithin dimples created in a portion of the top film 204. The top film istypically any flexible plastic liner that is a heat sealable or pressuresealable adhesive liner. Such liners will typically incorporatepolyesters or polyolefins as the flexible component capable of beingdimpled. One such specific liner is ACUOTE™ PK3RES product, which is asilicone coated polyester film exhibiting high strength, flexibility andgood chemical resistance. Another liner that may be utilized as the topfilm 204 is a high barrier aluminum oxide coated laminate of threelayers, one that is an aluminum oxide coated polyester, a middleadhesive layer, and a linear low-density sealant on the middle adhesivelayer that is available from TECHNIPAQ™. The packaging system of thepresent disclosure helps prevent harm to the dental composition or anypharmaceutical or food. In the case of the present dental compositions,the dental composition's finger malleable base materials are pliable andsusceptible to compressive forces. The packaging system is design tohave a stretched portion that, due to the stretching of the top film ononly a portion of the top film, significantly lessens the pressureapplied to the dental composition when the heat or pressure sealing stepis completed and thereby lessens the flattening of the product, whichcan also drive the surface powder ingredients into the bulk of thesilicone, which would decrease their efficacy.

The packaging system delivers the top film 204 from the main roll 216 oftop film 204 such that the top film travels along and/or around guiderollers 205. Along that path the top film is subjected to a compressivedimpling force from actuators 202. The actuators are typically rods thathave a rounded convex end that impact the film. The rounded convex endhelps prevent the film from being ripped or torn, which may occur if arounded surface on the impact member/actuators 202 is not used, when therods impact the film. As shown in FIG. 21 , this dimpling force appliedby the rod(s) stretches the film material in a center portion 218 of theend packaging that is aligned to be placed over the composition 200. Thedimpled film proceeds to the pressure or temperature sealing systemafter traveling under the guide roller 208, which has grooves 210therein that align with the dimpled portions of the top film 204 toprevent flattening or damage to the dimpled portion of the film. The topfilm is placed over the dental compositions that are traveling on thebottom film 212 such that each dental composition is positioned withinthe volume defined by the dimpled portion of the top film. Thereafter,heat or pressure is applied to the area 220 around each of the dentalcompositions to hygienically seal the dental composition within a largercavity 218 than what would be created if the dimpling has not beencreated. As a result, the malleable dental composition that is somewhatsusceptible to compression, is not compressed or flatten in asignificant manner which might have otherwise affected the functionalityof the dental composition.

Another aspect of the present disclosure includes dental compositionsthat are provisional (temporary), moisture curable dental cementcompositions. The dental cement compositions of the present disclosuremay be temporary, moisture-curable, dental cement compositions that havethe properties of being malleable and extrudable such that thecomposition can be extruded into rods through a die opening using thesystems described above. The dental cement compositions of the presentdisclosure in the form of extruded rods also typically have the abilityto support its own weight and hold its shape while being passed overrollers and cut into smaller pieces with a cutting blade and depositedonto a moving packaging liner as discussed in connection with othercompositions of the present disclosure. The dental cement compositionsaccording to this aspect of the present disclosure are typically free ofor at least substantially free of any uncured, uncrosslinked siliconehigh consistency rubber base material as this material may interferewith the curing of the dental cement composition. The dental cementcompositions of the present disclosure may be a dental cementcomposition of the type typically sold in a small bucket of multipledose quantity so long as the composition meets the extrudablecharacteristics contemplated in the context of this aspect of thepresent disclosure. One such dental cement that may be used is TEMPARIN®brand dental cement sold by DENTEK®. The dental cement composition ofthe present disclosure may include eugenol or be substantially free orfree of eugenol. A eugenol based dental cement contemplated may includethe following components: zinc oxide powder; calcium sulfate; petroleumjelly; potassium alum (potassium aluminum sulfate); paraffin, aluminumsulphate, aluminum phosphate, one or more essential oil components suchas menthol crystals (which may be removed if the menthol flavoring andother effects are not desired) and eugenol; and yellow iron oxide. Theamounts of paraffin and petroleum jelly, which operate as the basematerials for the dental cement may be lowered or raised to adjust theextrusion characteristics of the composition. The eugenol and zinc oxidein composition with the moisture present on the tooth or dentalcomponent operate to cure and provide the cementing function of thecompositions of the present disclosure. The extruded dental cementcompositions of the present disclosure further may include an appliedsurface composition, typically an adhesive composition to whichhypersensitivity desensitizing agents may also be added on at least onesurface thereof. The surface applied compositions are typically added tofurther enhance proper and easy adherence of the dental cementcomposition to a given location and provide a temporary bond until amore permanent albeit still temporary adherence of the dental cementbase can cure. Of course, the other functional compositions of thecoating compositions of the present disclosure described in connectionwith the compositions utilizing an uncured, uncrosslinked silicone highconsistency rubber base material may be utilized in the coatingcompositions applied to the extruded dental cement compositions of thepresent disclosure. Regardless of the extrudable, base dental cementcomposition(s) employed, the coating compositions, for example, mayinclude one desensitizing ingredient or a plurality of desensitizingingredients. Significantly, adding xanthan gum, a surface adhesive ofthe present composition into the base composition of the dental cementcompositions

It is also presently believed that extrudable dental cement compositionsof the present disclosure may also formed by modifying the amounts ofthe components of paste-like dental compositions currently sold in asmall rounded bucket like container such as certain DENTEMP® productsthat would otherwise not be extrudable without modification. TheDENTEMP® Loose Cap & Lost Filling Repair dental cement product is anon-extrudable paste in its form as currently marketed. As currentlyavailable on the market, the DENTEMP® Loose Cap & Lost Filling Repairdental cement product is sold in a single, multi-use bucket contain andthe composition includes: calcium sulfate, barium sulfate,dimethoxytetraethylene glycol, zinc oxide, eugenol, and anethylmethacrylate polymer. A related non-extrudable DENTEMP® product,the REFIL-IT® product, is also sold in a single, multi-use bucketcontainer and the composition is a eugenol free product that includes:calcium sulfate, barium sulfate, dimethoxytetraethylene glycol, zincoxide, ethylmethacrylate polymer, cherry flavor, and acesulfamepotassium, which is an artificial sweetener. However, it is presentlybelieved that the DENTEMP® Loose Cap & Lost Filling Repair dental cementcomposition as well as the REFIL-IT® compositions may be modified bylowering the amount of the solvent component of the dental composition,the dimethoxytetraethylene glycol and increasing the amount of the resincomponent, the ethylmethacrylate polymer. It is presently believed thatsuch a modification will result in a dental composition that may beextruded through the systems of the present disclosure, cut intoindividual use segments, optionally coated with a coating composition asdisclosed herein in connection with any of the base materials, andpackaged using the packaging systems of the present disclosure as well.This allows for the formation of sanitary, single use segments of eithercoated or uncoated dental cement compositions to be packaged rapidly andsafely. Moreover, such compositions may be applied using one's fingersby hand and without the use of tools such as a plastic applicator thatis necessary for the current dental cement products one the market.

Each of the different dental composition of the present disclosure maybe packaged in multi-unit boxes or other containers that are typicallyrectangular paper-based boxes such that a plurality of the single usedental composition may be packaged within a single overall boxedpackaging. This facilitates the sale and distribution of the multipleunits of the dental compositions of the present disclosure. Of course,the dental composition in the sealed systems of the present disclosurecould also be provide in single use only packaging at the retail orprofessional orthodontic offices. It is also conceivable that the dentalcompositions sealed in the systems of the present disclosure could bedispense on a rolled system similar to a toilet paper roll and anynumber of user selected amounts removed for use or distribution at onetime. Perforations typically exist around the side(s) of the seal aroundeach of the dental compositions to facilitate removal of one use of thedental composition from others on a same sheet of base layer film.

What is claimed is:
 1. A hygienically packaged composition comprising: abase layer of a thermoplastic film; a covering film layer that is a heatsealable or pressure sealable adhesive liner that covers thehygienically packaged composition wherein the hygienically packagedcomposition is chosen from the group consisting of a dental composition,a food composition, or a medicine and wherein the covering film layercomprises a stretched dimple in a portion of the covering film layerproximate the hygienically packaged composition thereunder the coveringfilm layer; and a heat or pressure seal between the base layer and thecovering film and around each hygienically packaged composition.
 2. Thehygienically packaged composition of claim 1, wherein the thermoplasticfilm is a polyolefin or a polyester or a poly-laminate film thatincludes a polyolefin or a polyester as one layer of the thermoplasticfilm.
 3. The hygienically packaged composition claim 1, wherein thecovering film layer is a barrier to bacteria and virus and is a flexibleplastic material and wherein the hygienically packaged composition is adental composition that is sealed within a volume between the base layerof the thermoplastic film and the covering film layer and wherein thedental composition is a tooth desensitizing dental composition having asurface composition on a surface of the tooth desensitizing dentalcomposition wherein the surface composition comprises potassium nitratein an amount up to about 5% by weight of the surface composition andstannous fluoride in an amount up to about 5% by weight of the surfacecomposition.
 4. The hygienically packaged composition of claim 3,wherein the covering film layer is a barrier to bacteria and virus andis a flexible plastic material and wherein the surface comprisespotassium nitrate in an amount from about 0.01% by weight of the surfacecomposition to about 0.5% by weight of the surface composition andstannous fluoride in an amount of from about 0.01% by weight of thesurface composition to about 0.5% by weight of the surface composition.5. The hygienically packaged composition of claim 3, wherein thecovering film layer comprises polyesters or polyolefins and wherein thesurface composition comprises potassium nitrate in an amount from about0.01% by weight of the surface composition to about 0.5% by weight ofthe surface composition and stannous fluoride in an amount of from about0.01% by weight of the surface composition to about 0.5% by weight ofthe surface composition.
 6. The hygienically packaged composition ofclaim 1, wherein the hygienically packaged composition is a dentalcomposition and the dental composition is at least substantiallycuboidal shaped having an exterior facing surface and wherein the dentalcomposition adheres to a damaged tooth surface that is wet with salivawithin about 8 seconds and wherein the dental composition is chosen fromthe group consisting of: an extrudable dental cement composition that isextrudable through a die at a temperature of from about 10° C. to about50° C.; an extrudable base material that is extrudable through a die ata temperature of from about 10° C. to about 100° C.; wherein theextrudable base material comprises at least one compound chosen from thegroup consisting of: (A) a product consisting of one or morehydrocarbon-based waxes and optionally also one or more inorganicfiller, one or more organic filler, or one or more inorganic and organicfillers; (B) an uncured, uncrosslinked silicone high consistency rubberbase; and (C) a hydrophobic water insoluble solid material that ismalleable at 37° C. or lower and safe for a human oral environment; andwherein the extrudable base material has a surface composition appliedthereon wherein the surface composition comprises: potassium nitrate,stannous fluoride, and at least one dry, powdered hydrophilic polymericsubstance engaged with and dispersed on one or more surface of theextrudable base material.
 7. The hygienically packaged composition ofclaim 6, wherein the at least one dry, powdered hydrophilic polymericsubstance is chosen from the group consisting of: apolyvinylpyrrolidone, a polyoxazoline, a polyethylene glycol, a starch,a polyacrylic acid, a carbomer, a polyvinyl alcohol, a polyvinylacetate, a cellulose derivative, a polysaccharide, a polyacrylamide, aN-vinyl caprolactam polymer, a copolymer of methyl vinyl ether andmaleic anhydride (PVM/MA), and blends of any of the above and thewherein the surface composition comprises potassium nitrate in an amountfrom about 0.01% by weight of the surface composition to about 0.5% byweight of the surface composition and stannous fluoride in an amount offrom about 0.01% by weight of the surface composition to about 0.5% byweight of the surface composition.
 8. The hygienically packagedcomposition of claim 6, wherein the at least one dry, powderedhydrophilic polymeric substance consists of a polysaccharide and thepolysaccharide is a xanthan gum, a pectin, a guar gum that has beenpartially hydrated to greater than 12% by weight water but still inpowder form, a starch, a cellulose ether, or a chitosan derivative. 9.The hygienically packaged composition of claim 7, wherein the dentalcomposition is finger force malleable at room temperature and the dentalcomposition further comprises a colorant.
 10. The hygienically packagedcomposition of claim 6, wherein the dental composition is the extrudablebase material and the extrudable base material has a textured surfaceand wherein the surface composition is mechanical engaged with anddispersed on the textured surface of the extrudable base material. 11.The hygienically packaged composition of claim 10, wherein theextrudable base material is a cuboid and has the surface composition ona totality of only one surface thereof.
 12. The hygienically packagedcomposition of claim 6, wherein the dental composition is at leastsubstantially a cuboid shape having a first substantially planar surfaceand wherein the surface composition is mechanical engaged to theextrudable base material and dispersed over an entirety of a surfacearea of the first substantially planar surface.
 13. The hygienicallypackaged composition of claim 6, wherein the dental composition isconfigured to adhere to exposed dentinal tubules and the dentalcomposition is at least substantially cuboidal shaped and has at leastone exterior facing surface and wherein the dental composition comprisesthe surface composition applied to the at least one exterior facingsurface and wherein the dental composition adheres to a damaged toothsurface that is wet with saliva within about 8 seconds.
 14. Thehygienically packaged composition of claim 13, wherein the at least onedry, powdered hydrophilic polymeric substance is chosen from the groupconsisting of: a polyvinylpyrrolidone, a polyoxazoline, a polyethyleneglycol, a starch, a polyacrylic acid, a carbomer, a polyvinyl alcohol, apolyvinyl acetate, a cellulose derivative, a polysaccharide, apolyacrylamide, a N-vinyl caprolactam polymer, a copolymer of methylvinyl ether and maleic anhydride (PVM/MA), and blends of any of theabove.
 15. The hygienically packaged composition of claim 13, whereinthe at least one dry, powdered hydrophilic polymeric substance is axanthan gum, a pectin, a guar gum that has been partially hydrated togreater than 12% by weight water but still in powder form, a starch, acellulose ether, or a chitosan derivative.
 16. The hygienically packagedcomposition of claim 13, wherein the at least one dry, powderedhydrophilic polymeric substance comprises one or more water-solublepolymeric adhesive.
 17. The hygienically packaged composition of claim13, wherein the dental composition has a textured surface thereon andthe at least one dry, powdered hydrophilic polymeric substance ismechanical engaged with and dispersed on the textured surface of thedental composition.
 18. The hygienically packaged composition of claim6, wherein the dental composition comprises a plurality of individualdental compositions each separately hygienically sealed and connectedwith one another and sharing the same layer of the thermoplastic filmand sharing the same covering layer and wherein a series of perforationsto facilitate disengagement of one packaged dental composition from theplurality of individual dental compositions is present in a spacebetween each of the plurality of individual dental compositions whilenot present on the seal between the layer of the thermoplastic film andthe covering layer.
 19. A hygienically packaged composition having aninterior that contains the hygienically packaged composition wherein thehygienically packaged composition is chosen from the group consisting ofa dental composition, a medicine, and a food composition, wherein thehygienically packaged composition comprises a base layer with a baselayer perimeter portion and a base layer interior facing portion and atop layer having a top layer perimeter portion and a top layer interiorfacing portion wherein (1) the base layer interior facing portion, (2)the top layer interior facing portion, or (3) both of the base layerinterior facing portion and the top layer interior facing portion areflexed to create a stretched film portion of the base layer interiorfacing portion, a stretched film portion of the top layer interiorfacing portion, or both a stretched film portion of the base layerinterior facing portion and a stretched film portion of top layerinterior facing portion and wherein the base layer perimeter portion andthe top layer perimeter portion are heat sealed or pressure sealedtogether along the top layer perimeter portion and the base layerperimeter portion and wherein the hygienically packaged composition ispositioned between the base layer interior facing portion and the toplayer interior facing portion proximate the stretched film portion ofthe base layer interior facing portion, the stretched film portion ofthe top layer interior facing portion, or both the stretched filmportion the base layer interior facing portion and the stretched filmportion of top layer interior facing portion.
 20. At least onehygienically packaged tooth desensitizing dental composition comprising:a base layer that is a thermoplastic film; a covering film having asurface area wherein the covering film is a heat sealable or pressuresealable adhesive liner that covers a tooth desensitizing dentalcomposition and having a flexed and thinner surface area positioned overthe tooth desensitizing dental composition; a hygienic seal around thetooth desensitizing dental composition; and wherein the toothdesensitizing dental composition has a coating composition applied to atleast one surface thereof that comprises (1) potassium nitrate in anamount of from about 0.15 to about 0.5 weight percent of the coatingcomposition (2) stannous fluoride in an amount of from about 0.15 toabout 0.5 weight percent of the coating composition and (3) at least onedry, powdered hydrophilic polymeric component that is chosen from thegroup consisting of: a polyvinylpyrrolidone, a polyoxazoline, apolyethylene glycol, a starch, a polyacrylic acid, a carbomer, apolyvinyl alcohol, a polyvinyl acetate, a cellulose derivative, apolysaccharide, a polyacrylamide, a N-vinyl caprolactam polymer, acopolymer of methyl vinyl ether and maleic anhydride (PVM/MA), andblends.